Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

Phase 4

Withdrawn

• Conditions: Travelers' Diarrhea
• Interventions: Drug: Rifaximin

• Registration Number: NCT00875875
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:

1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR

2. a single 600 mg dose of rifaximin daily for 3 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-03
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Study Start: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-08
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted.
• is > 18 years of age
• has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness
• has acute diarrhea less than 1 week's duration
• willingness to provide a diarrhea stool sample
• willingness to keep a daily diary for 5 days
• signed informed consent

Exclusion Criteria

• fever or bloody diarrhea
• has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline)
• is pregnant now, likely to become pregnant, or breast-feeding
• has duration of diarrhea of greater than 1 weeks
• is allergic to Rifampin or Rifaximin
• has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder
• is more than moderately dehydrated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Rifaximin	This is the same dose as the standard dose, given once daily (200 mg)
1	Rifaximin	This is the approved treatment regimen for travelers' diarrhea (600 mg)

Primary Outcome Measures

Name	Time	Method
Time from beginning therapy to passage of last unformed stool	5 days

Secondary Outcome Measures

Name	Time	Method
Side effects as reported by the subjects on diaries	5 days

Trial Locations

Locations (1)

Enteric Disease Clinic; 🇲🇽 Guadalajara, Jalisco, Mexico